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Sameer J Khandhar,
Hirosada Yamamoto, Jeffrey J Teuteberg,
Michael A Shullo,
Hiram G Bezerra,
Marco A Costa,
Faith Selzer,
Joon S Lee,
Oscar C Marroquin,
Dennis M McNamara,
Suresh R Mulukutla,
Catalin Toma
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ABSTRACT: BACKGROUND: Optical coherence tomography (OCT) is a novel intravascular imaging modality with excellent spatial resolution. This study explored the utility of OCT in cardiac transplantation for the detection and characterization of early changes associated with coronary allograft vasculopathy (CAV). METHODS: Fifteen consecutive patients, 1 to 4 years after transplant with no angiographic evidence of CAV, underwent successful OCT imaging using the Fourier-domain OCT system (C7-XR, St. Jude Medical, St. Paul, MN) in the left anterior descending artery. Analysis included measurements of the lumen, intima, and media layers, and characterization of atherosclerotic plaques. Patients were stratified by intima-to-media (I/M) ratio and classified as normal (≤1) or abnormal (>1). RESULTS: Patients were a mean of 2.8 years after transplant, 58 years old, and 92% were men. OCT imaging revealed 8 of 15 patients had intimal hyperplasia with an I/M ratio >1. Comparing those with I/M ratio of ≤1 and >1, the median (interquartile range) intimal thickness was greater (75 [70-101] vs 206 [97-269]μm, p = 0.03), whereas the media thickness was no different (72 [70-103] vs 94 [73-113]μm, p = 0.53). In addition, 7 of 15 patients had lipid-rich or calcified atherosclerotic plaques. CONCLUSIONS: OCT provides high-resolution quantitative imaging of the coronary arteries and its use allows for detailed assessment of the coronary artery wall and early morphologic changes that occur after cardiac transplantation. The clinical predictive value of these OCT-derived measurements remains to be determined.
The Journal of heart and lung transplantation: the official publication of the International Society for Heart Transplantation 03/2013; · 3.54 Impact Factor
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ABSTRACT: BACKGROUND: Heart transplantation in adults with congenital heart disease (CHD) has historically been associated with sub-optimal survival compared with other indications for transplantation. The purpose of this study was to evaluate survival outcomes after heart transplantation in a contemporary cohort of adults with CHD and to identify risk factors for mortality that may help guide recipient and donor selection. METHODS: We performed a retrospective analysis of our adult heart transplant database, from January 2001 to February 2011, identifying 19 patients who underwent transplantation for CHD. These patients were compared with a control group of 428 patients who underwent transplantation for indications other than CHD. Kaplan-Meier survival analysis and Cox regression modeling were performed. RESULTS: The mean age for the CHD group was 39.4 ± 13 years vs 54.7 ± 12 years (p < 0.001). There was no significant difference in survival (CHD vs control) at 30 days (89% vs 92%, p = 0.5567), 1 year (84% vs 86%, p = 0.6976) or 5 years (70% vs 72%, p = 0.8478). The only significant predictor of death in the CHD group was donor organ ischemic time >4 hours (HR 13.26, 95% CI 1.3 to 132.2, p = 0.028). There was no significant correlation with recipient age, history of failed Fontan surgery, pre-operative ventilator use, donor:recipient weight ratio <0.8, donor:recipient CMV mismatch, model for end-stage liver disease (MELD) score or percent reactive antibody >10%. CONCLUSIONS: In the modern era, with careful donor and recipient selection, adults with CHD have excellent early and mid-term survival after heart transplantation, rivaling that of recipients with other indications for transplantation.
The Journal of heart and lung transplantation: the official publication of the International Society for Heart Transplantation 03/2013; · 3.54 Impact Factor
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ABSTRACT: Ventricular assist devices provide therapeutic options for patients with severe heart failure who have exhausted available medical therapies. With restoration of organ perfusion with ventricular assist devices, the heart failure resolves and quality of life and functional status improve. The current generation of continuous-flow devices present novel challenges to the clinical assessment of patients by substantially reducing or nearly eliminating any palpable pulse. Patients therefore generally have inadequate arterial pulsatility for most noninvasive monitoring devices such as pulse oximeters or automated blood pressure cuffs to work accurately. This article describes the function of continuous-flow devices and how this function affects common monitoring options, as well as how to clinically assess recipients of continuous-flow devices to promptly identify those whose condition may be deteriorating or who may be receiving inadequate perfusion.
Progress in transplantation (Aliso Viejo, Calif.) 03/2013; 23(1):39-46. · 1.03 Impact Factor
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Kathleen L Lockard,
Carrie Allen,
Douglas Lohmann,
Donald A Severyn,
Richard D Schaub,
Kelly E Kauffman,
Jeffrey R Hodges,
Lorna Woodhall,
Ramesh Ramanathan, Jeffrey J Teuteberg,
Chad E Eckert,
Robert L Kormos
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ABSTRACT: A patient with a HeartMate II left ventricular assist device who had a body mass index of 52 needed gastric bypass surgery in order to qualify for a heart transplant. Unlike previous experience in which the surgery was performed at the implant hospital, the gastric bypass surgery in this case was performed at a bariatric center of excellence that was a separate facility from the implant hospital. The artificial heart program of the University of Pittsburgh Medical Center worked with the bariatric center of excellence in scheduling the gastric bypass surgery using a multidisciplinary team approach at 2 hospitals to coordinate safe, high-quality patient care in a unique situation.
Progress in transplantation (Aliso Viejo, Calif.) 03/2013; 23(1):28-32. · 1.03 Impact Factor
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ABSTRACT: This study sought to assess the utility of the Destination Therapy Risk Score (DTRS) in patients with continuous flow left ventricular assist devices (LVAD).
The DTRS was developed to predict the risk of 90-day in-hospital mortality with pulsatile flow LVAD as destination therapy (DT). Despite ongoing use in patients with continuous flow devices, its utility has not been studied in such populations.
The DTRS was determined in 1,124 patients with the continuous flow HeartMate II (Thoratec Corporation, Pleasanton, California) LVAD as a bridge to transplant (BTT, n = 486) and DT (n = 638) and 114 DT patients with the pulsatile flow HeartMate XVE (Thoratec Corporation). Patients were divided into risk groups based on DTRS: low (0-8), medium (9-16), and high (>16).
The 90-day in-hospital mortality for low-, medium-, and high-risk groups was 8%, 7%, and 16%, respectively, for BTT patients; 9%, 12%, and 19%, respectively, for DT patients; and 11%, 18%, and 25%, respectively, for XVE DT patients. The high-risk groups had more than a 2-fold increased risk of mortality compared with the low-risk groups. However, the area under the receiver-operating characteristic curve for 90-day in-hospital mortality yielded modest values ranging from 0.54 to 0.58 for the HeartMate II BTT and DT groups, respectively. Survival rates over 2 years were statistically significantly different as stratified by the 3 DTRS groups for patients implanted for DT but not for BTT.
DTRS provides poor discrimination of mortality for BTT patients and only modest discrimination for DT patients receiving continuous flow LVAD.
Journal of the American College of Cardiology 04/2012; 60(1):44-51. · 14.16 Impact Factor
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ABSTRACT: The Model for End-stage Liver Disease (MELD) score is a marker of multisystem organ dysfunction. It has been used to predict outcomes in patients undergoing hepatic and nonhepatic interventions. End-stage heart disease exhibits a varying degree of multiorgan dysfunction, which impacts the adverse events related to ventricular assist device (VAD) therapy. Our aim for the present study was to investigate the value of MELD score in predicting adverse events related with VAD therapy.
Data were collected on demographics, clinical characteristics, MELD score; Interagency Registry for Mechanically Assisted Circulatory Support-defined VAD adverse events within the first 6 months, and survival from VAD recipients (n=286; from 1996 to 2009). Univariable, multivariable, and Cox regression analyses were performed using SAS software (SAS Institute, Cary, NC).
The mean MELD score was 14.4±5.9. Actuarial incidence of infections, bleeding events, and cardiovascular dysfunction at 6 months was 65.4%, 52.1%, and 45.6%, respectively. Multivariable Cox proportional hazards model (controlling for gender, type of device, diagnosis, intention to treat, urgency, and inotropic use) confirmed that MELD score predicted mortality, respiratory, and renal dysfunction at 6 months (p<0.01).
Preoperative MELD score is predictive of mortality, respiratory, and renal dysfunction at 6 months after controlling for gender, type of device, diagnosis, intention to treat, urgency, and inotropic use. The MELD score may be used as a quantitative tool to assess the adverse events associated with VAD therapy.
The Annals of thoracic surgery 04/2012; 93(5):1541-7; discussion 1547-8. · 3.74 Impact Factor
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ABSTRACT: Right ventricular (RV) failure is a significant complication after implantation of a left ventricular assist device (LVAD). It is therefore important to identify patients at risk a priori. However, prognostic models derived from multivariate analyses have had limited predictive power.
This study retrospectively analyzed the records of 183 LVAD recipients between May 1996 and October 2009; of these, 27 later required a RVAD (RVAD(+)) and 156 remained on LVAD only (RVAD(-)) until transplant or death. A decision tree model was constructed to represent combinatorial non-linear relationships of the pre-operative data that are predictive of the need for RVAD support.
An optimal set of 8 pre-operative variables were identified: transpulmonary gradient, age, right atrial pressure, international normalized ratio, heart rate, white blood cell count, alanine aminotransferase, and the number of inotropic agents. The resultant decision tree, which consisted of 28 branches and 15 leaves, identified RVAD(+) patients with 85% sensitivity, RVAD(-) patients with 83% specificity, and exhibited an area under the receiver operating characteristic curve of 0.87.
The decision tree model developed in this study exhibited several advantages compared with existing risk scores. Quantitatively, it provided improved prognosis of RV support by encoding the non-linear, synergic interactions among pre-operative variables. Because of its intuitive structure, it more closely mimics clinical reasoning and therefore can be more readily interpreted. Further development with additional multicenter, longitudinal data may provide a valuable prognostic tool for triage of LVAD therapy and, potentially, improve outcomes.
The Journal of heart and lung transplantation: the official publication of the International Society for Heart Transplantation 12/2011; 31(2):140-9. · 3.54 Impact Factor
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ABSTRACT: Obesity and heart failure are increasingly common, but the outcomes, weight changes, and adverse events of patients with advanced heart failure and obesity on mechanical support is not well described.
We retrospectively reviewed all non-underweight patients with durable mechanical support at a single institution from January 2000 until December 2008 and compared outcomes, weight change, and Interagency Registry for Mechanically Assisted Circulatory Support-defined adverse events between obese and nonobese patients.
A total of 169 patients were included; 113 (67%) nonobese and 56 (33%) obese. Baseline characteristics, pump types, and implant duration were similar for both populations with the exception of more diabetes (61% vs 26%, p < 0.0001) and hypertension (61% vs 42%, p = 0.019) in the obese. Outcomes on mechanical support at 6 months were not different between groups. There was no significant difference between the nonobese and obese groups in the change in body mass index (-0.3 vs -1.0 mg/m(2), p = 0.29) over the duration of support. Obese patients, as compared with the nonobese, had higher incidence rates of sepsis (64.5% vs 34.7%, respectively, p = 0.006) and reoperation for infectious complications (34.2% vs 13.3%, respectively, p = 0.014). Obese patients also had a higher cumulative incidence of sepsis and reoperation for infection. Two-year posttransplant outcomes were not different in the obese and nonobese.
Obese patients have similar outcomes on mechanical support, but at the cost of a higher cumulative incidence of sepsis and reoperations for infection; however, obese patients lose little weight while on mechanical support.
The Annals of thoracic surgery 10/2011; 92(4):1420-6. · 3.74 Impact Factor
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Madhurmeet Singh,
Michael Shullo,
Robert L Kormos,
Kathleen Lockard,
Rachelle Zomak,
Marc A Simon,
Christian Bermudez,
Jay Bhama,
Dennis McNamara,
Yoshiya Toyoda, Jeffrey J Teuteberg
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ABSTRACT: Renal dysfunction is common before mechanical circulatory support (MCS). Mechanical circulatory support frequently improves renal function, but the impact of pre-MCS renal dysfunction on renal function after cardiac transplantation (CTX) is unknown.
Patients with MCS from January 1995 until April 2008 at a single center were included if their MCS duration was at least 60 days and they underwent successful CTX. Patients were followed for 1 year after CTX.
A total of 116 patients were included in the study. Mechanical circulatory support was biventricular assist device in 28% and left ventricular assist device in 72% (continuous flow left ventricular assist device, 14%). Mean duration of MCS was 124 days. Patients were grouped according to tertiles of pre-MCS creatinine clearance (CrCl): group 1, CrCl less than 45 mL/min; group 2, CrCl between 45 and 65 mL/min inclusive; and group 3, CrCl more than 65 mL/min. Group 3 had the best renal outcomes both after MCS and 1 year after CTX. Regardless of group, patients who had a CrCl of at least 60 mL/min before CTX had similar 1-year posttransplant CrCl (55 versus 53 versus 56 mL/min for groups 1 through 3, respectively; not significantly different). However, the ability to achieve this level of renal function after MCS was less likely in those with the worst renal function before the initiation of MCS (53% versus 74% versus 90% for groups 1 through 3, respectively; p=0.001).
The use of MCS leads to improvements in renal function in patients after MCS. However, the renal outcomes after CTX seem to be more dependent on the level of renal function achieved during MCS than on the level of renal function before MCS.
The Annals of thoracic surgery 05/2011; 91(5):1348-54. · 3.74 Impact Factor
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ABSTRACT: Calcineurin inhibitor (CNI)-associated renal insufficiency is common after cardiac transplantation (CTX); however, the addition of sirolimus allows for CNI dose reduction and this strategy may limit CNI renal toxicity. This study examines the long-term effects of such a strategy. METHODS: Patients from a single center who had CTX from 1990 to 2007 and who were converted to sirolimus and a dose-reduced CNI were compared to group-matched controls maintained on CNI and an antiproliferative agent. RESULTS: One hundred and fifty-five patients (79 sirolimus and 76 controls) were included and had similar baseline characteristics. Sirolimus was started a mean of 1429 d post-CTX and maintained for a mean of 823 d. Reason for conversion to sirolimus was renal insufficiency (34%), vasculopathy (29%), recurrent rejection (19%), and other (18%). The eGFR was not different between groups at baseline (44.7 mL/min/1.73 m(2) vs. 46.0, p = 0.64) or at any point during follow-up: 90 d, 180 d, 1 yr, 2 yr, and 3 yr. conclusion: Patients converted to a regimen of sirolimus and a dosed-reduced CNI have stable renal function over the following three yr, but do not have an improvement in renal outcomes compared to patients maintained on full dose CNI.
Clinical Transplantation 02/2011; 26(1):42-9. · 1.67 Impact Factor
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ABSTRACT: Risk stratification for mechanical circulatory support (MCS) has emerged as an important tool in patient selection and outcomes assessment. Most studies examining risk stratification have been limited to pulsatile devices. We use the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS) to stratify patients with continuous-flow devices and assess outcomes in less severe, but functionally impaired, heart failure patients.
This study included 101 bridge-to-transplant and destination-therapy patients at 3 centers. Three groups were studied: Group 1, cardiogenic shock (INTERMACS Profile 1); Group 2, inotrope-dependent (INTERMACS Profile 2 or 3); and Group 3, ambulatory advanced heart failure (INTERMACS Profiles 4 to 7). The outcomes of interest were actuarial survival, survival to discharge and length of stay.
Survival at 36 months was better in Group 3 than in Group 1 (95.8% vs 51.1%, p = 0.011), but not between Groups 2 and 3 (68.8 vs 95.8%, p = 0.065). Lengths of stay for Groups 1 to 3 were 44, 41 and 17 days: Groups 1 vs 3, p < 0.001; Groups 2 vs 3, p < 0.001; and Groups 1 vs 2, p = 0.62. Lengths of stay for survivors were 49, 39 and 14 for the 3 groups: Groups 1 vs 3, p < 0.001; Groups 2 vs 3, p < 0.001; and Groups 1 vs 2, p = 0.28.
INTERMACS classification is a useful metric for risk-stratifying candidates for MCS. Less acutely ill but functionally impaired heart failure patients receiving continuous-flow LVADs had longer short- and long-term survival and shorter lengths of stay compared with patients who were more acutely ill.
The Journal of heart and lung transplantation: the official publication of the International Society for Heart Transplantation 12/2010; 30(4):402-7. · 3.54 Impact Factor
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ABSTRACT: Ventricular assist devices (VADs) provide effective treatment for end-stage heart failure; however, most patients experience > or =1 major adverse events (AEs) while on VAD support. Although early, non-fatal AEs may increase the risk of later death during VAD support, this relationship has not been established. Therefore, we sought to determine the impact on 1-year mortality of AEs occurring during the first 60 days of VAD support.
A retrospective analysis was performed using prospectively collected data from a single-site database for patients aged > or =18 years receiving left ventricular or biventricular support during 1996 to 2008 and who survived >60 days on VAD support. Fourteen major classes of AEs occurring during this 60-day period were examined. One-year survival rates of patients with and without each major AE were compared.
The study included 163 patients (80% men; mean age, 49.5 years), of whom 87% were European American, 72% had left ventricular support, and 83% were bridge to transplant. The occurrence of renal failure, respiratory failure, bleeding events, and reoperations during the first 60 days after implantation significantly increased the risk of 1-year mortality. After controlling for gender, age, VAD type, and intention to treat, renal failure was the only major AE significantly associated with later mortality (hazard ratio, 2.96; p = .023).
Specific AEs, including renal failure, respiratory and bleeding events, and reoperations, significantly decrease longer-term survival. Renal failure conferred a 3-fold increased risk of 1-year mortality. Peri-operative management should focus on strategies to mitigate risk for renal failure in order to maximize later outcomes.
The Journal of heart and lung transplantation: the official publication of the International Society for Heart Transplantation 09/2010; 29(9):981-8. · 3.54 Impact Factor
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ABSTRACT: With the increasing availability of pigs genetically engineered to protect their tissues from the human immune response, research into xenotransplantation is progressing steadily. One potential route to the clinic would be the use of a pig heart as a bridge to allotransplantation. This would only be ethical if the outcome was realistically estimated to be as good as, or better than, bridging with a mechanical device. The experimental results that would be required to warrant consideration of a clinical trial and the patients in whom bridging with a xenograft might be considered preferable to a mechanical device are discussed.
The Journal of heart and lung transplantation: the official publication of the International Society for Heart Transplantation 08/2010; 29(8):838-40. · 3.54 Impact Factor
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Kathleen L Lockard,
Ashley Weimer,
Genevieve O'Shea,
Erin Driggers,
Linda Conroy, Jeffrey J Teuteberg,
Stephen Winowich,
Douglas Lohmann,
Richard D Schaub,
Donald A Severyn,
Robert L Kormos
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ABSTRACT: The Centers for Medicare and Medicaid Services announced that all hospitals implanting ventricular assist devices are required to have certification from the The Joint Commission for disease-specific care destination therapy with a ventricular assist device effective March 27, 2009, in order to receive Medicare reimbursement for services rendered to patients who have devices implanted for destination therapy. On February 23, 2007, The Joint Commission released the certification requirements for ventricular assist devices implanted for destination therapy in an 8-page document so that hospitals could prepare to meet the 2009 certification deadline. The Artificial Heart Program of the University of Pittsburgh Medical Center undertook a multidisciplinary project, under the guidance of the nurse coordinator, to prepare the hospital and program for a precertification survey by The Joint Commission for disease-specific destination therapy ventricular assist device certification. The Presbyterian Hospital Artificial Heart Program was awarded The Joint Commission's device-specific certification for destination therapy with ventricular assist devices in June 2008.
Progress in transplantation (Aliso Viejo, Calif.) 06/2010; 20(2):155-62. · 1.03 Impact Factor
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Robert L Kormos, Jeffrey J Teuteberg,
Francis D Pagani,
Stuart D Russell,
Ranjit John,
Leslie W Miller,
Todd Massey,
Carmelo A Milano,
Nader Moazami,
Kartik S Sundareswaran,
David J Farrar
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ABSTRACT: The aim of this study was to evaluate the incidence, risk factors, and effect on outcomes of right ventricular failure in a large population of patients implanted with continuous-flow left ventricular assist devices.
Patients (n = 484) enrolled in the HeartMate II left ventricular assist device (Thoratec, Pleasanton, Calif) bridge-to-transplantation clinical trial were examined for the occurrence of right ventricular failure. Right ventricular failure was defined as requiring a right ventricular assist device, 14 or more days of inotropic support after implantation, and/or inotropic support starting more than 14 days after implantation. Demographics, along with clinical, laboratory, and hemodynamic data, were compared between patients with and without right ventricular failure, and risk factors were identified.
Overall, 30 (6%) patients receiving left ventricular assist devices required a right ventricular assist device, 35 (7%) required extended inotropes, and 33 (7%) required late inotropes. A significantly greater percentage of patients without right ventricular failure survived to transplantation, recovery, or ongoing device support at 180 days compared with patients with right ventricular failure (89% vs 71%, P < .001). Multivariate analysis revealed that a central venous pressure/pulmonary capillary wedge pressure ratio of greater than 0.63 (odds ratio, 2.3; 95% confidence interval, 1.2-4.3; P = .009), need for preoperative ventilator support (odds ratio, 5.5; 95% confidence interval, 2.3-13.2; P < .001), and blood urea nitrogen level of greater than 39 mg/dL (odds ratio, 2.1; 95% confidence interval, 1.1-4.1; P = .02) were independent predictors of right ventricular failure after left ventricular assist device implantation.
The incidence of right ventricular failure in patients with a HeartMate II ventricular assist device is comparable or less than that of patients with pulsatile-flow devices. Its occurrence is associated with worse outcomes than seen in patients without right ventricular failure. Patients at risk for right ventricular failure might benefit from preoperative optimization of right heart function or planned biventricular support.
The Journal of thoracic and cardiovascular surgery 05/2010; 139(5):1316-24. · 3.41 Impact Factor
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ABSTRACT: Severe pulmonary hypertension (PH) in heart failure (HF) is a risk factor for adverse outcomes after heart transplantation (HTx). Left ventricular assist devices (LVADs) improve pulmonary hemodynamics, but our understanding of the degree of improvement and the effect on outcomes is still evolving.
We reviewed invasive pulmonary hemodynamics from 58 consecutive patients receiving LVAD support as a bridge to HTx from 1996 to 2003. The primary outcome was change in baseline transpulmonary gradient (TPG) during LVAD support and after HTx/recovery. The secondary outcome was post-HTx survival.
All patients (age, 49 +/- 14 years, 79% male, 40% ischemic) received a pulsatile LVAD (median support, 97 days; interquartile range [IQR], 31-222). Hemodynamic measurements were obtained at baseline (median, 1 day; IQR, 1-3), during early (median, 1 day; IQR, 0-4) and late (median, 75 days; IQR, 24-186) LVAD support, and after HTx/recovery (median, 28 days; IQR, 17-40). Improvement in TPG occurred throughout LVAD support and was sustained after HTx/recovery. Levels of TPG reductions in patients with a baseline TPG in the highest quartile (14.1-26.0 mm Hg) were 8.6 +/- 3.5 vs 6.5 +/- 3.1 mm Hg in the lowest quartile (2.0-7.7 mm Hg) during LVAD support (p = 0.102), with 90% vs 100% 30-day post-HTx survival (P = 0.113).
Pulmonary hemodynamics and post-HTx survival were similar after pulsatile LVAD support in patients with and without pre-implant PH. LVAD support may be a useful strategy to reverse PH in carefully selected patients, thus improving candidacy for HTx.
The Journal of heart and lung transplantation: the official publication of the International Society for Heart Transplantation 02/2010; 29(2):201-8. · 3.54 Impact Factor
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Jay K Bhama,
Steven Rayappa,
Diana Zaldonis,
Prasad S Adusumilli,
Aditya Bansal,
Elizabeth A Genovese, Jeffrey J Teuteberg,
Yoshiya Toyoda,
Michael P Siegenthaler,
Christian A Bermudez,
Kenneth R McCurry,
Robert L Kormos
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ABSTRACT: Mechanical circulatory support (MCS) is life sustaining for patients with end-stage heart failure. Most devices require abdominal wall transgression, creating a potential for abdominal complications. The incidence and impact of these relatively underreported complications are unknown.
A retrospective review was performed on 179 patients who received MCS therapy from 1999 to 2008. Abdominal complications were grouped as abdominal wall, gastrointestinal tract, and solid organ.
Ninety-eight patients (55%) experienced 157 abdominal complications. These involved the abdominal wall in 69 (44%), the gastrointestinal tract in 52 (33%), and the solid organs in 36 (23%). Surgical intervention was required in 36% of patients with abdominal wall complications, 19% of patients with gastrointestinal tract complications, and 14% of patients with solid organ complications. Multivariate analysis identified diabetes mellitus (p < 0.001), emergent device placement (p = 0.019), and preimplant mechanical ventilation (p = 0.045) as independent risk factors for developing an abdominal complication. Kaplan-Meier survival while receiving MCS was significantly reduced for patients with abdominal complications versus those without (p = 0.0142). Multivariate analysis identified only solid organ abdominal complications (p = 0.001) as an independent risk factor for death while receiving device support.
Abdominal complications are common in patients supported with MCS devices and significantly reduce survival. Surgical intervention is more frequently required for complications related to the abdominal wall compared with other complications. Patients with significant comorbidities (diabetes mellitus, respiratory failure) requiring urgent or emergent device placement are at higher risk for the development of abdominal complications with an attendant reduction in device-related survival.
The Annals of thoracic surgery 02/2010; 89(2):522-8; discussion 528-9. · 3.74 Impact Factor
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Elizabeth A Genovese,
Mary Amanda Dew, Jeffrey J Teuteberg,
Marc A Simon,
Joy Kay,
Michael P Siegenthaler,
Jay K Bhama,
Christian A Bermudez,
Kathleen L Lockard,
Steve Winowich,
Robert L Kormos
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ABSTRACT: Although ventricular assist devices (VADs) provide effective treatment for end-stage heart failure, VAD support remains associated with significant risk for adverse events (AEs). To date there has been no detailed assessment of the incidence of a full range of AEs using standardized event definitions. We sought to characterize the frequency and timing of AE onset during the first 60 days of VAD support, a period during which clinical observation suggests the risk of incident AEs is high.
A retrospective analysis was performed utilizing prospectively collected data from a single-site clinical database including 195 patients aged 18 or greater receiving VADs between 1996 and 2006. Adverse events were coded using standardized criteria. Cumulative incidence rates were determined, controlling for competing risks (death, transplantation, recovery-wean).
During the first 60 days after implantation, the most common AEs were bleeding, infection, and arrhythmias (cumulative incidence rates, 36% to 48%), followed by tamponade, respiratory events, reoperations, and neurologic events (24% to 31%). Other events (eg, hemolysis, renal, hepatic events) were less common (rates <15%). Some events (eg, bleeding, arrhythmias) showed steep onset rates early after implantation. Others (eg, infections, neurologic events) had gradual onsets during the 60-day period. Incidence of most events did not vary by implant era (1996 to 2000 vs 2001 to 2006) or by left ventricular versus biventricular support.
Understanding differential temporal patterns of AE onset will allow preventive strategies to be targeted to the time periods when specific AE risks are greatest. The AE incidence rates provide benchmarks against which future studies of VAD-related risks may be compared.
The Annals of thoracic surgery 10/2009; 88(4):1162-70. · 3.74 Impact Factor
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ABSTRACT: Short-term mechanical circulatory support may be lifesaving in patients with right ventricular (RV) failure related to post-cardiotomy cardiogenic shock (PCCS), cardiac transplantation (CTx), and long-term therapy with a left ventricular assist device (LVAD). This study evaluates our clinical experience using the CentriMag (Levitronix LLC, Waltham, Mass) system for temporary mechanical RV support.
A retrospective review was performed of 29 patients (mean age, 57 +/- 14 years) in whom the CentriMag system was used for RV support from September 2005 to March 2008.
The indication for RV support was PCCS in 7 (24%), CTx in 10 (35%), and LVAD placement in 12 (41%). The mean support time was 8 +/- 8 days. The device was successfully weaned in 3 PCCS patients (43%), 7 CTx patients (70%), and 7 LVAD patients (58%). Complications included major infection (pneumonia, sepsis, or LVAD pocket infection) in 13 (45%), arrhythmia in 13 (45%), reoperation for bleeding in 10 (35%), stroke/encephalopathy in 3 (10%), and air embolism in 1 (3%). Early mortality (< 30 days or before discharge) occurred in 14 patients (48%) of which 9 (31%) died with the device in place. Late death occurred in 2 of 15 patients (13%) who survived to discharge. There were no device failures.
The CentriMag system provides effective temporary mechanical circulatory support for RV failure. Ease of implantation and a high rate of successful device weaning justify the use of the CentriMag system for temporary RV support.
The Journal of heart and lung transplantation: the official publication of the International Society for Heart Transplantation 10/2009; 28(9):971-6. · 3.54 Impact Factor
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ABSTRACT: The HeartMate II (Thoratec, Pleasanton, CA) is an effective bridge to transplantation (BTT) but requires anti-coagulation with warfarin and aspirin. We evaluated the risk of thromboembolism and hemorrhage related to the degree of anti-coagulation as reflected by the international normalized ratio (INR).
INRs were measured monthly for 6 months in all discharged HeartMate II BTT patients and at an event. Each INR was assigned to ranges of INRs. Adverse events analyzed were ischemic and hemorrhagic stroke, pump thrombosis, and bleeding requiring surgery or transfusion. Events were correlated to the INR during the event and at the start of the month.
In 331 patients discharged on support, 10 had thrombotic events (9 ischemic strokes, 3 pump thromboses), and 58 had hemorrhagic events (7 strokes, 4 hemorrhages requiring surgery, and 102 requiring transfusions). The median INR was 2.1 at discharge and 1.90 at 6 months. Although the incidence of stroke was low, 40% of ischemic strokes occurred in patients with INRs < 1.5 and 33% of hemorrhagic strokes were in patients with INRs > 3.0. The highest incidence of bleeding was at INRs > 2.5.
The rate of thromboembolism during long-term outpatient support with the HeartMate II is low. The low number of thrombotic events appears to be offset by a greater number of hemorrhagic events. An appropriate target INR is 1.5 to 2.5 in addition to aspirin therapy. In patients having recurrent episodes of bleeding, the risk of lowering the target INR appears to be small.
The Journal of heart and lung transplantation: the official publication of the International Society for Heart Transplantation 10/2009; 28(9):881-7. · 3.54 Impact Factor
